Impact of Prior Cytoreductive Nephrectomy on Efficacy in Patients with Synchronous Metastatic Renal Cell Carcinoma Treated with Avelumab plus Axitinib or Sunitinib : Post Hoc Analysis from the JAVELIN Renal 101 Phase 3 Trial

GND
115682899
ORCID
0000-0003-3084-8654
Affiliation
Jena University Hospital
Grimm, Marc-Oliver;
Affiliation
Keio University School of Medicine, Tokyo, Japan
Oya, Mototsugu;
Affiliation
Dana-Farber Cancer Institute, Boston, MA, USA
Choueiri, Toni K;
Affiliation
dMemorial Sloan Kettering Cancer Center, New York, NY, USA
Motzer, Robert J;
Affiliation
Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
Schmidinger, Manuela;
Affiliation
University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA
Quinn, David I;
Affiliation
Institut Paoli-Calmettes, Aix-Marseille University, INSERM, CNRS, CRCM, Marseille, France
Gravis-Mescam, Gwenaelle;
Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy
Verzoni, Elena;
Affiliation
Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands
Van den Eertwegh, Alfonsus J M;
Affiliation
Pfizer SRL, Milan, Italy
di Pietro, Alessandra;
Affiliation
Pfizer SRL, Milan, Italy
Mariani, Mariangela;
Affiliation
Pfizer, Cambridge, MA, USA
Wang, Jing;
Affiliation
Pfizer, Athens, Greece
Thomaidou, Despina;
Affiliation
Roussy Cancer Campus, University of Paris Saclay, Villejuif, France
Albiges, Laurence

Data on the effects of prior cytoreductive nephrectomy (CN) in patients with renal cell carcinoma (RCC) with synchronous metastases (M1 disease) before immune checkpoint inhibitor (ICI) treatment are limited. In this post hoc analysis of treatment-naive patients with advanced RCC from the phase 3 JAVELIN Renal 101 trial, we assessed efficacy outcomes in the avelumab + axitinib and sunitinib arms in patients who were initially diagnosed with M1 disease (n = 412) grouped by prior CN (yes vs no). Progression-free survival (PFS) and overall survival (OS) were analyzed using multivariable Cox regression, and objective response rates (ORRs) were analyzed using logistic regression. After adjusting for imbalances in baseline variables, the hazard ratio (HR) for PFS in the prior CN versus no prior CN subgroup was 0.79 (95% confidence interval [CI] 0.53-1.16) in the avelumab + axitinib arm, and 1.15 (95% CI 0.77-1.70) in the sunitinib arm. The corresponding HRs for OS were 0.59 (95% CI 0.38-0.93) and 0.86 (95% CI, 0.55-1.34), and the odds ratios for ORR were 2.67 (95% CI 1.32-5.41) and 2.02 (95% CI 0.82-4.94), respectively. Prospective studies of the potential benefits of CN and its appropriate timing in patients receiving first-line treatment with ICI-containing combinations are warranted. PATIENT SUMMARY: This study looked at patients with kidney cancer whose disease had already spread outside the kidneys when it was first detected. We found that patients whose kidney had been removed before starting treatment with avelumab + axitinib had better outcomes than those whose kidney had not been removed. For patients treated with sunitinib, the results were more similar between the groups with and without prior kidney removal. However, statistical tests did not find any significant differences. The JAVELIN Renal 101 trial is registered on ClinicalTrials.gov as NCT02684006.

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